New legislation, expiring patents and increasing healthcare costs call for decisive changes in the global pharmaceutical industry. New markets for specialty medicines, biopharmaceuticals and biosimilars are opening up, entailing opportunities for further growth. The coming years will see markets across the globe implement new best practices and manufacturing concepts. What they all have in common is the need for safe, high-quality and consistent operations.
A TRILLION HERE, A TRILLION THERE
According to a recent report by the IMS Institute of Healthcare Informatics¹, total annual spending on medicines is set to reach the $1 trillion threshold in 2014 and continue to rise to $1.2 trillion in 2017. After a period of turmoil due to patent expiries and austerity measures following the economic crisis, the developed markets are now starting to rebound. The U.S. is forecasted to resume increased spending following implementation of the Affordable Care Act. In Japan, the threat of rapidly increasing medical demands from the aging population urged the government to an unprecedented decision – by 2018, 60 percent of all off-patent prescription drugs are to be dispensed as generics. Overall, lower-cost generic alternatives will continue to have the largest impact on growth. Generic producers and contract manufacturers require very robust and flexible machinery with high output, while complex medicines for targeted treatment demand flexible platforms and smaller batch sizes.
The pharmerging markets will still be extending their progress by 10 to 13 percent, as population increases and rising incomes contribute to dramatically higher use of medicines. Improved access to drugs is supported by economic expansion, significant demographic and epidemiologic changes, and a broad range of government and private healthcare policies. China, the primary growth driver in Asia and beyond to date, now also faces a period of modest decline compared to recent years². This will not only affect local manufacturers but also pharmaceutical producers from the developed countries, who have built a large manufacturing and distribution network in China and have been rewarded with unparalleled revenues. India’s healthcare sector, on the other hand, does not seem to stop growing. Pharmaceutical exports from India are forecasted to increase more than twofold³ over the next four years, if India succeeds in meeting regulatory challenges.
REQUIRING FLEXIBILITY AND SAFETY
Robust and powerful machines remain the first choice for manufacturing companies in the emerging markets. Generic producers especially want to achieve the highest possible productivity at lowest possible costs. Many drug manufacturers have shifted their focus to the development of new drug formulations and have outsourced their end production such as filling and closing operations and secondary packaging to contract manufacturers. Their main concerns are flexibility and productivity – primary and secondary packaging machines must be adaptable to different products, packaging formats and speeds at consistently high output rates.
Although large-scale production of blockbuster products and generics is still the most prominent manufacturing assignment of the emerging markets, some countries like India also observe a shift to more complex formulations, which has led to a higher demand for sophisticated technologies. The trend towards small amounts of targeted drugs, particularly for the treatment of cancer, calls for flexible platforms that can handle small batches while ensuring the highest safety for both operators and products. Biopharmaceuticals, vaccines and anti-virals must be manufactured and packaged with the utmost caution and attention-to-detail.
BIOPHARMA’S PATENT CLIFF LOOMING
Having left the largest part of the generic patent cliff behind, the pharmaceutical industry now faces a new challenge. The patents of several large, biotech molecules are about to expire, opening the doors for biosimilar production. In 2002, biologics represented 11 percent of total drug sales; now IMS estimates biologic agents will continue to outpace overall pharma spending and will represent close to 20 percent of the total market value by 2017. Monoclonal antibodies and human insulin will further spur this growth. Biosimilars account for less than 0.5 percent of biologic spending in mature markets; in emerging markets, non-original biologics represent more than 10 percent of all biologics spending, and counting.
Biopharmaceuticals and their successors all require intensive research and development, as well as sophisticated equipment and contamination-free raw materials, such as Purified and Highly Purified Water and Water for Injection, generated by sophisticated high purity media systems. To deliver the best possible product to patients, drug manufacturers count on safe processing and packaging solutions, while patients rely on their preferred drug delivery devices for safe administration.
As far as these devices are concerned, the pharmaceutical industry has successfully focused its development activities on even safer and easier administration. Although oral dosage forms are more convenient, parenteral administration has taken its place as the most effective and safe treatment. For many biological products there is yet no alternative to parenteral administration. The development of new drug delivery devices increasingly focuses on patients’ individual needs4. Insulin pens, for example, have been optimized with respect to convenience and ease of use, while the devices generally tend to be smaller and safer to handle.